Biosimilar-Related Appeals Pending before the Federal Circuit

There are presently seven biosimilar-related appeals pending before the Federal Circuit. Two of those appeals, Amgen v. Sandoz (Case No. 18-1551) and Amgen v. Coherus (Case No. 18-1993), are from district court judgments in favor of the biosimilar applicants.  The other five appeals are from final written decisions of the Patent Trial and Appeals Board (PTAB) in inter partes review (IPR) proceedings.  Below we summarize these seven pending Federal Circuit appeals, which range from recently filed to awaiting decision.  (Tables summarizing all pending and completed biosimilar-related Federal Circuit appeals can be found here.)

APPEALS FROM DISTRICT COURTS

Amgen v. Sandoz, Case No. 18-1551 (consolidated)

  • an appeal from the Northern District of California, Civil Action Nos. 14-4741 & 16-2581

On February 5, 2018, Amgen appealed to the Federal Circuit from the district court’s judgment that Sandoz’s filgrastim and pegfilgrastim biosimilars do not infringe Amgen’s protein purification patent (U.S. Patent No. 8,940,878) and method of treatment patent (U.S. Patent No. 6,162,427). In ruling in favor of Sandoz on the ’878 patent on summary judgment, the district court found that Sandoz’s purification process did not infringe the ’878 patent under the district court’s claim construction order, either literally or under the doctrine of equivalents, because the method claimed in the ’878 patent requires separate washing and eluting steps, whereas Sandoz’s purification method involves a simultaneous washing and eluting step.  With regard to the ’427 patent, Amgen had stipulated earlier in the case to withdraw the patent based on the district court’s claim construction order but subject to appeal.

In its opening appellate brief, filed April 13, 2018, Amgen challenged the district court’s claim construction and summary judgment rulings, raising four overarching grounds for reversal or remand. First, Amgen argued the district court erred as a matter of law because in granting summary judgment the court interpreted the “washing” and “eluting” claim elements of the ’878 patent to require the washing and eluting steps to be temporally and compositionally distinct, which was allegedly different from how the court interpreted the claims in its claim construction order.  Second, Amgen argued the district court erred as a matter of law in granting summary judgment because there were outstanding disputed issues of material fact regarding whether Sandoz’s process infringes the ’878 patent.  Third, Amgen argued the district court erred because it denied Amgen additional discovery regarding a modified manufacturing process that Sandoz was developing.  Fourth, Amgen argued the district court erred as a matter of law in construing the claim term “chemotherapeutic agent” in the ’427 patent to require treatment of disease, instead of permitting it to work in combination with G-CSF to enhance stem cell mobilization.  Amgen had only stipulated to withdraw its allegations of infringement based on the district court’s claim construction and seeks a remand to litigate the ’427 patent based on a modified construction.  Sandoz challenged Amgen’s positions on appeal in its responsive brief, filed June 22, 2018, which we recently summarized here.

Amgen’s reply brief is due July 20, 2018. Based on that deadline, a Federal Circuit panel will likely hear oral argument in the first quarter of 2019.

Amgen v. Coherus, Case No. 18-1993

  • an appeal from the District of Delaware, Civil Action No. 17-546

On May 17, 2018, Amgen appealed to the Federal Circuit from the district court’s order dismissing Amgen’s patent infringement complaint regarding Coherus’s aBLA for a pegfilgrastim biosimilar. In the complaint, Amgen had asserted infringement of U.S. Patent No. 8,273,707, directed to a protein purification process.  In granting Coherus’ motion to dismiss, the district court found that Coherus’ process used a particular combination of salts that was different from the process claimed in the ’707 patent and that Amgen was barred under the doctrine of prosecution history estoppel from asserting claims against salt combinations other than those claimed in the patent.

Amgen’s opening appellate brief is due July 20, 2018.

APPEALS FROM THE PTAB

Momenta v. Bristol-Myers Squibb, Case No. 17-1694

  • an appeal from the PTAB, IPR2015-01537

On February 22, 2017, Momenta appealed to the Federal Circuit from the PTAB’s final written decision upholding the patentability of U.S. Patent No. 8,476,239, which is directed to stable liquid formulations of the molecule CTLA4Ig, the active ingredient in Orencia® (abatacept). In reaching its decision, the PTAB found that the claims of the ’239 patent were not obvious in view of the cited prior art.

The parties fully briefed the appeal in the third quarter of 2017 and, on December 5, 2017, there was oral argument before a panel comprising Judges Newman, Dyk and Chen. Momenta has argued that the PTAB erred because its factual findings did not match the conclusion with regard to obviousness and that the prior art provided sufficient guidance to lead to the development of the claimed formulation.  In addition to taking issue with Momenta’s arguments regarding the PTAB’s decision of non-obviousness, Bristol-Myers Squibb has argued that Momenta’s appeal should be dismissed outright because Momenta lacks Article III standing to appeal the PTAB’s decision given that Momenta does not market a product within the purview of the patent claims and is “years away” from filing an FDA application to market any such product.  In its response, Momenta has argued that it has standing to appeal because, among other things, the PTAB’s decision causes Momenta concrete economic harm in light of Momenta’s significant financial investment in developing its abatacept biosimilar.

Last month the parties submitted supplemental letters to the Federal Circuit regarding the standing issue. A decision is expected within the coming months and could issue at any time.

AbbVie v. Coherus & Boehringer Ingelheim, Case No. 17-2304 (consolidated)

  • an appeal from the PTAB, IPR2016-00172, -188, -189, -408, -409

This is a consolidated appeal from five final written decisions of the PTAB finding the claims of U.S. Patent Nos. 8,889,135, 9,017,680, and 9,073,987 unpatentable for obviousness in view of the prior art. The three challenged patents are directed to methods for treating rheumatoid arthritis (RA) using biweekly 40 mg subcutaneous (SC) injections of the antibody D2E7 (i.e., adalimumab).  Coherus filed IPRs against all three patents, and Boehringer Ingelheim (BI) filed two IPRs against the ’135 patent.  The PTAB found that a person of ordinary skill in the art would have been motivated to develop and administer D2E7 according to the claimed regimen with a reasonable expectation that it would successfully treat rheumatoid arthritis.  The PTAB reasoned that the prior art reported clinical trials showing that biweekly 40 mg IV doses of D2E7 were effective in treating RA, that weekly 20, 40 and 80 mg SC doses were effective in treating RA, and that SC administration was comparable to IV administration.

In July 2017, AbbVie appealed to the Federal Circuit from the five unfavorable PTAB decisions. The five appeals were consolidated later that year.  In its opening appellate brief, filed December 13, 2017, AbbVie has rgued that the PTAB’s obviousness analysis was flawed because, among other things, it wrongly shifted the burden of persuasion from the petitioners to AbbVie.  AbbVie has also argued that the PTAB misinterpreted a prior art reference that indicated that RA patients on a 40 mg dosing regimen were withdrawn or up-dosed during a clinical study, which, according to AbbVie, taught away from using the claimed dosing regimen.  In their responsive briefs, filed March 23, 2018, Coherus and BI have argued that, among other things, the PTAB had not shifted the burden of establishing unpatentability from petitioners and that the PTAB’s decision was supported by substantial evidence.  AbbVie filed its reply brief on May 4, 2018.

The consolidated appeal is fully briefed and is awaiting an oral argument date. Oral argument will likely be scheduled for late 2018.

Celltrion & Pfizer v. Biogen, Case No. 18-1885 (consolidated)

  • an appeal from the PTAB, IPR2016-01614, IPR2017-01115

On April 25, 2018, Celltrion and Pfizer appealed to the Federal Circuit from the PTAB’s final written decision upholding the patentability of the instituted claims of U.S. Patent No. 7,820,161, directed to methods of treating RA using rituximab and methotrexate. The PTAB ruled the claims of the ’161 patent were not obvious over the asserted prior art references because the PTAB found insufficient evidence that the Rituxan Label qualifies as a prior art publication and that the remaining asserted publications were insufficient to establish obviousness.

Celltrion and Pfizer’s opening brief is due August 13, 2018.

Pfizer v. Genentech, Case No. 18-1933

  • an appeal from the PTAB, IPR2016-01837

On May 7, 2018, Genentech appealed to the Federal Circuit from the PTAB’s final written decision finding the instituted claims of U.S. Patent No. 7,807,799 unpatentable for anticipation and/or obviousness in view of the prior art. The ’799 patent is directed to a protein purification method using protein A affinity chromatography at a temperature in the range from about 10 °C. to about 18 °C.  (The ’799 patent’s specification discusses using the method in connection with trastuzumab—a biosimilar of which Pfizer is pursuing.) According to the PTAB, the prior art taught that protein A chromatography may be used to purify antibodies at the claimed temperature range.

Genentech’s opening appellate brief is due August 17, 2018.

Hospira v. Genentech, No. 18-1959

  • an appeal from the PTAB, IPR2016-01771

On May 10, 2018, Genentech appealed to the Federal Circuit from the PTAB’s final written decision finding the claims of U.S. Patent No. 7,622,115 unpatentable for obviousness, but not anticipation, in view of the prior art. The ’115 patent is directed to a method for treating cancer using bevacizumab and assessing the patient for gastrointestinal perforation during the treatment.  According to the PTAB, while a single prior art reference disclosed the treatment of cancer using bevacizumab, it failed to explicitly or inherently disclose the requirement for “assessing the patient for gastrointestinal perforation.”  However, the PTAB concluded that assessing the patient for gastrointestinal perforation was obvious in view of the standard of care and the knowledge of a person of ordinary skill in the art that gastrointestinal perforation is a known potential adverse event.

Genentech’s opening appellate brief is due August 20, 2018.

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